Subject: CNN ACTHAR Response
Date: Thursday, June 21, 2018 at 4:29:01 PM Eastern Daylight Time
From: Grace Wright
To:
Drash, Wayne
CC:
Goldberg, Steven
Wayne,
Thank you for your e-mail, and thank you, also, for the opportunity to respond. I appreciate it.
If I can begin by addressing your first set of quesRons:
As you may know, for many years, the voluntary PhRMA Code on InteracRons with Health Care Professionals (known
as the “PhRMA Code”) has been the industry standard for health care professionals’ dealings with the pharmaceuRcal
industry. The Code incorporates all applicable legal requirements, as well as the highest ethical standards, to ensure
that the pharmaceuRcal industry and providers avoid even the appearance of impropriety. A copy of the PhRMA
Code is available at this link: hYp://phrmadocs.phrma.org/sites/default/files/pdf/phrma_markeRng_code_2008.pdf
I have always complied with the requirements of the PhRMA Code, including in my interacRons with Mallinckrodt and
Questcor. To the very best of my knowledge, Mallinckrodt and Questcor fully comply with the requirements of the
PhRMA Code as well.
Now if I may take a moment to comment on the medical issues you raise:
Rheumatologists, like myself, care for paRents with mulRple chronic and disabling diseases. These diseases include
rheumatoid arthriRs and other inflammatory arthriRses, inflammatory myosiRs, scleroderma, lupus, sarcoidosis, and
vasculiRs. Many of those diseases are also complicated by other condiRons, such as inflammatory eye disease,
osteoporosis, intersRRal lung disease, stroke, and heart disease.
The discovery of corRcosteroids such as prednisone and related steroids was indeed a breakthrough in the
management of these diseases. However, that breakthrough did not lead to a true modificaRon of the course of the
disease, and, in fact, caused many of the complicaRons noted above. In the a^ermath, both syntheRc and biological
disease modifying anR-rheumaRc drugs and targeted small molecules were developed in an aYempt to adequately
control these diseases. But many paRents have refractory disease that does not respond to any of these therapies,
and requires the addiRon of mulRple other agents. Most paRents lose response to their prescribed therapies and
ulRmately are forced to switch. This can occur as quickly as 3-6 months, and on average every 3 years depending on
the disease in quesRon.
All of these therapies are extremely costly, and this cost only increases whenever a switch in therapies is required.
Therapies like Acthar are used to bridge flares in some of these paRents, and may in fact be the only therapy yet
available to them. Inflammatory myosiRs, a condiRon leading to loss of muscle bulk and funcRon caused by
autoimmune and inflammatory aYack on muscles can result in complete disability, loss of respiratory funcRon, and
loss of swallowing, both of which result in death. IVIG (pooled human Immunoglobulin, blood product) is used in
these paRents at tremendous cost, and may be parRally or minimally effecRve in a refractory populaRon. The
mortality rate in these paRents can be quite high, as is the burden of care for the paRent, family, and healthcare
team.
As an educator and speaker, it is essenRal to me that prescribers understand how to use—and in whom not to use—
various therapies. These therapies all come with potenRal adverse consequences and significant price tags. Sadly,
we, the physicians and prescribers, do not determine the price of drugs.
I hope that this response is helpful to you as you finish your work on this story, and again, I appreciate the

 opportunity to comment.
Sincerely,

Grace C. Wright, MD